MINI 6800 DIGITAL MOBILE C-ARM

Image-intensified Fluoroscopic X-ray System, Mobile

GE DEC MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Ge Dec Medical Systems with the FDA for Mini 6800 Digital Mobile C-arm.

Pre-market Notification Details

Device IDK992506
510k NumberK992506
Device Name:MINI 6800 DIGITAL MOBILE C-ARM
ClassificationImage-intensified Fluoroscopic X-ray System, Mobile
Applicant GE DEC MEDICAL SYSTEMS 384 WRIGHT BROTHERS DR. Salt Lake City,  UT  84116
ContactTed L Parrot
CorrespondentTed L Parrot
GE DEC MEDICAL SYSTEMS 384 WRIGHT BROTHERS DR. Salt Lake City,  UT  84116
Product CodeOXO  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-07-27
Decision Date1999-08-19
Summary:summary

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